BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22475073 · Received July 10, 2025

    Report

    Report Number
    3012018285-2025-00004
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    June 10, 2025
    Report Date
    July 10, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT ENCOMPASSES THREE TREATMENT ATTEMPTS WITH THE CERENE CRYOTHERAPY DEVICE MADE ON (B)(6) 2025 THAT RESULTED IN THE PATIENT NOT RECEIVING TREATMENT AND HAVING AN MRI POST-PROCEDURE. IT WAS THIS MRI THAT WAS DETERMINED TO BE AN "OTHER SERIOUS IMPORTANT MEDICAL EVENT," THEREBY PROMPTING A RE-EVALUATION OF THE INITIAL COMPLAINT. THE MANUFACTURER BECAME AWARE OF THIS INTERVENTION ON JUNE 10TH, 2025. THE FIRST AND SECOND DEVICES WERE RETURNED ON JUNE 5, 2025. THE THIRD DEVICE WAS RETURNED ON JUNE 10, 2025. BASED ON THE RESULTS FROM ANALYSIS OF THE DEVICE LOG AND INSPECTION OF THE RETURNED DEVICES, THE ROOT CAUSES FOR THE PRODUCT PROBLEMS ARE AS FOLLOWS: THE ROOT CAUSE FOR THE FIRST DEVICE (EC120 - SHEATH RETRACTED WITHOUT VACUUM, PRE-INSERTION) WAS USER ERROR. THE USER APPEARS TO HAVE RETRACTED THE SHEATH PRIOR TO POWERING ON THE DEVICE WHICH TRIGGERED THE EC120 ERROR CODE. THE ROOT CAUSE FOR THE SECOND AND THIRD DEVICES (EC300 - POSSIBLE PERFORATION) APPEARS TO BE DUE TO A NON-DEVICE RELATED ISSUE THAT CAUSED THE LINER TO INFLATE FOR AN EXTENDED LENGTH OF TIME, THEREBY TRIGGERING A POSSIBLE PERFORATION MESSAGE IN THE ABSENCE OF A UTERINE PERFORATION. THERE WERE NO OBSERVATIONS OF NOTE FOR THE RETURNED DEVICES UPON VISUAL INSPECTION, THE DEVICES PASSED ALL TESTS WHEN RE-TESTED, AND THE REPORTED PRODUCT PROBLEM COULD NOT BE REPRODUCED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    WHILE ATTEMPTING TO PERFORM AN ENDOMETRIAL CRYOABLATION ON A PATIENT WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN HAD DIFFICULTY DILATING THE PATIENT'S CERVIX (WHICH THE PATIENT REPORTED AS BEING VERY PAINFUL) AND INSERTED THE DEVICE INTO THE PATIENT PRIOR TO TURNING THE DEVICE ON. THE PHYSICIAN THEN REMOVED THE DEVICE FROM THE PATIENT AND TURNED IT ON, AT WHICH POINT THE DEVICE REPORTED ERROR CODE 120 (SHEATH RETRACTED WITHOUT VACUUM, PRE-INSERTION). THE PHYSICIAN PROCEEDED TO REATTEMPT THE PROCEDURE WITH ANOTHER DEVICE AND TURNED ON THE DEVICE PRIOR TO INSERTION INTO THE PATIENT, AS PER THE INSTRUCTIONS FOR USE, WHILE USING ULTRASOUND DURING INSERTION TO VIEW THE LOCATION OF THE DEVICE (PROBE) AND CONFIRM PROPER PLACEMENT AT THE FUNDUS. AFTER INITIAL DEVICE LINER DEPLOYMENT AND SAFETY CHECKS, THE DEVICE REPORTED AN ERROR CODE "POSSIBLE PERFORATION." AS PER THE IFU "TREATMENT STATUS & NEXT STEPS," THE PHYSICIAN PROCEEDED TO REATTEMPT THE PROCEDURE FOR A 3RD TIME WITH THE THIRD DEVICE ALSO REPORTING AN ERROR CODE "POSSIBLE PERFORATION." THE PHYSICIAN ELECTED TO STOP ANY FURTHER ATTEMPTS, AND THE PATIENT WAS DISCHARGED WITHOUT TREATMENT. THE PATIENT REPORTED THE DAY AFTER THE ATTEMPTED PROCEDURES THAT SHE DOES NOT HAVE AND HAS NEVER HAD A PERFORATED UTERUS. IN THE SUBSEQUENT WEEK(S) AFTER THE UNSUCCESSFUL TREATMENT ATTEMPTS, THE PATIENT REPORTED THAT SHE RECENTLY HAD UNDERGONE AN MRI OF THE PELVIS, WHICH CONFIRMED NO EVIDENCE OF UTERINE RUPTURE, THINNING, OR WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730297 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 108645587 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other