BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22982474 · Received September 5, 2025

    Report

    Report Number
    3012018285-2025-00007
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 5, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANY DEVICE MALFUNCTION DURING TREATMENT CAN POTENTIALLY LEAD TO A USER ELECTING TO PERFORM A REPEAT ENDOMETRIAL ABLATION, WHICH CAN POSE A SERIOUS RISK TO HEALTH. LABELING FOR THE CERENE CRYOTHERAPY DEVICE STATES THAT THE "TREATMENT STATUS AND NEXT STEPS" FOR ERROR CODE 307 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    THE PHYSICIAN ENCOUNTERED A DEVICE MALFUNCTION WHILE USING THE CERENE CRYOTHERAPY DEVICE. THE DEVICE OPERATED NORMALLY UNTIL SHORTLY AFTER ACTIVE ABLATIVE TREATMENT HAD STARTED, AT WHICH TIME THE LCD SCREEN DISPLAYED ERROR CODE 307 (SHEATH ENCODER FAULT, TREATMENT). THE DEVICE WAS REMOVED AND THE PHYSICIAN ELECTED TO USE ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED WITH NO INJURY. ANALYSIS OF THE RETURNED DEVICE SHOWED THAT THE EC 307 WAS TRIGGERED AFTER 11 SECONDS OF NITROUS OXIDE TREATMENT; NO FAULT OR OTHER ISSUES WERE OBSERVED DURING RE-TESTING OF THE SUBJECT DEVICE. THE CONCLUSION OF THE INVESTIGATION IS THAT THE MOST LIKELY ROOT CAUSE FOR THE EC 307 WAS AN UNDETERMINED ISSUE WITH THE SHEATH ENCODER PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263925 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 112041066 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female