BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22680984 · Received July 31, 2025

    Report

    Report Number
    3012018285-2025-00006
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 3, 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
    TX, 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 301 IS "UTERUS PARTIALLY TREATED, END PROCEDURE, DO NOT RE-TREAT." NO INJURY OR ADVERSE EVENTS WERE REPORTED. DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    BASED ON EVALUATION OF THE RETURNED DEVICE, THE DATA LOG INDICATED THAT THE DEVICE PERFORMED AS INTENDED. THE USER WAS PROMPTED TO RETRACT THE SHEATH TO THE FINAL CAVITY LENGTH, AFTER WHICH THE BUTTON WAS PUSHED TO CONFIRM A 2.5CM CAVITY LENGTH AND THEN PUSHED AGAIN TO PROCEED WITH INFLATION CYCLES AND TREATMENT. THE DEVICE WAS PAUSED AFTER 12 SECONDS OF NITROUS OXIDE TREATMENT. EC 301 WAS DUE TO USE ERROR - THE USER DID NOT RETRACT THE SHEATH TO THE MEASURED CAVITY LENGTH WHEN PROMPTED AND PAUSED THE DEVICE ONCE NITROUS OXIDE TREATMENT STARTED, TRIGGERING EC 301.

    Description of Event or Problem · 0

    DURING AN ENDOMETRIAL ABLATION WITH THE CERENE CRYOTHERAPY DEVICE, THE PHYSICIAN BELIEVED THE DEVICE STARTED TREATMENT WITH THE CAVITY LENGTH SET TO 2.5CM. AS THE PHYSICIAN WAS UNSURE OF THE CAVITY LENGTH SETTING, A COMPANY REPRESENTATIVE WHO WAS PRESENT DIRECTED THE PHYSICIAN TO PAUSE THE DEVICE AFTER 8-10 SECONDS OF CRYOTHERAPY HAD ELAPSED AND BEGIN VENTING THE DEVICE. ERROR CODE 301 WAS SHOWN ON THE DEVICE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278197 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 112041064 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female