BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 23660166 · Received November 26, 2025

    Report

    Report Number
    3012018285-2025-00010
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    October 27, 2025
    Report Date
    November 26, 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 INTERRUPTION OF 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. APPROXIMATELY 90 SECONDS INTO NITROUS OXIDE TREATMENT, THE DEVICE SHOWED ERROR CODE 390, STOPPING TREATMENT. THE PHYSICIAN REMOVED THE DEVICE AND ELECTED TO USE ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH A FULL TREATMENT, AND THE PATIENT WAS DISCHARGED. NO ADVERSE EVENTS WERE REPORTED. EVALUATION OF THE LOG DATA FROM THE RETURNED DEVICE SHOWED THAT THE DEVICE WAS PAUSED ~75 SECONDS INTO NITROUS OXIDE TREATMENT WITH EC390 REPORTED 15 SECONDS LATER WHEN THE DEVICE WAS NOT UN-PAUSED WITHIN THE ALLOWABLE WINDOW. AS THERE WERE NO ISSUES OBSERVED WITH THE DEVICE DURING RE-TESTING, THIS WAS DETERMINED TO BE USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148065 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 113050519 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female