BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 22501342 · Received July 14, 2025

    Report

    Report Number
    3012018285-2025-00005
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    April 18, 2025
    Report Date
    July 14, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    POST-PROCEDURAL PAIN/DISCOMFORT IS A KNOWN ADVERSE EVENT, WHICH IS DOCUMENTED IN THE LABELING AS PELVIC PAIN, UTERINE CRAMPS, UTERINE TENDERNESS, POSTOPERATIVE CRAMPING, AND ABDOMINAL PAIN AND/OR BLOATING.

    Description of Event or Problem · 0

    ON (B)(6) 2025 AN ALLEGED PATIENT POSTED HER EXPERIENCE WITH THE CERENE PROCEDURE ON AN INTERNET CHAT BOARD. THE PATIENT IS A 44 Y/O FEMALE WHO HAD THE CERENE PROCEDURE PERFORMED IN HER DOCTOR'S OFFICE ON (B)(6) 2025. THE PATIENT STATES SHE TOOK A 10MG VALIUM AND MOTRIN PRE-PROCEDURE, AS PRESCRIBED BY HER DOCTOR. AFTER LEAVING THE PHYSICIAN'S OFFICE FOLLOWING THE PROCEDURE (WHICH SHE STATES PROCEEDED NORMALLY), THE PATIENT STATES SHE EXPERIENCED SEVERE PAIN (REPORTED AT A LEVEL 10/10) THAT REQUIRED HER TO GO TO THE EMERGENCY ROOM, WHERE SHE WAS GIVEN IV PAIN MEDICATION FOR APPROXIMATELY 7 HOURS. THE PATIENT STATES SHE WAS EVALUATED AT THE HOSPITAL AND DID NOT REPORT ANY FINDINGS FROM THIS EVALUATION. AFTER DISCHARGE, THE PATIENT REPORTED THAT HER PAIN WAS AT A LEVEL 2/10 AND GRADUALLY TAPERED OFF. IN AN UPDATE ON THE SAME CHAT BOARD ON(B)(6) 2025, THE PATIENT STATED SHE WAS NO LONGER IN ANY PAIN AND HER PERIOD SEEMED LIGHTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395105 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention