BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 25165730 · Received May 13, 2026

    Report

    Report Number
    3012018285-2026-00001
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    UDI-DI
    00850008595035
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE, AS THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS REPORTED, SO DEVICE HISTORY RECORDS WERE REVIEWED, WITH NO DEVIATIONS IN THE PRODUCTION RECORD NOTED. FOUR EPISODES OF PRESYNCOPE WERE REPORTED IN THE CLARITY PIVOTAL STUDY FOR THE CERENE CRYOTHERAPY DEVICE AND ARE REPORTED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    PRIOR TO TREATMENT WITH THE CERENE CRYOTHERAPY DEVICE, THE PATIENT RECEIVED A PARACERVICAL BLOCK AND EXPERIENCED RINGING IN HER EARS AND A RACING HEART. AFTER 2-2.5 HOURS OF WAITING AT THE PHYSICIAN'S FACILITY, THE PATIENT AND PHYSICIAN DECIDED TO PROCEED WITH CERENE TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESFULLY. FOLLOWING THE PROCEDURE, THE PATIENT WAS ACCOMPANIED TO THE PARKING LOT BY HER HUSBAND, WHERE SHE LOST CONSCIOUSNESS. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY ROOM AND ACCOMPANIED BY THE PHYSICIAN. THE PATIENT WAS RELEASED THE SAME DAY FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390136 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 114226858 00850008595035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization