BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22163244 · Received June 7, 2025

    Report

    Report Number
    3012018285-2025-00003
    Event Type
    Malfunction
    Date Received
    June 7, 2025
    Date of Event
    May 9, 2025
    Report Date
    June 6, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 390 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 BEGAN TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE WITHOUT ISSUE. AFTER 67 SECONDS OF TREATMENT, THE DEVICE SHOWED ERROR CODE 379 AND STOPPED TREATMENT. THE PHYSICIAN REMOVED AND VENTED THE DEVICE, AND ELECTED TO OPEN A SECOND 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
    603543 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 110199742 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female