BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 23206047 · Received October 2, 2025

    Report

    Report Number
    3012018285-2025-00008
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    July 3, 2025
    Report Date
    October 2, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS DISCARDED AT THE TIME OF TREATMENT AND SEVERAL LOT NUMBERS WERE SOLD TO THIS PHYSICIAN, IT WAS NOT POSSIBLE TO ISOLATE THE DEVICE LOT NUMBER. AS DEVICE INVESTIGATION AND REVIEW OF PRODUCTION RECORDS SPECIFIC TO THE DEVICE USED FOR THIS PROCEDURE WERE NOT POSSIBLE, THE INVESTIGATION WAS LIMITED TO COMMUNICATION/INTERVIEWS. HEAVY BLEEDING, SPOTTING, CRAMPING, AND HEMORRHAGE ARE ALL KNOWN ADVERSE EVENTS ASSOCIATED WITH ENDOMETRIAL ABLATION AND PRESENTED IN THE LABELING FOR THE CERENE CRYOTHERAPY DEVICE.

    Description of Event or Problem · 0

    THE PATIENT HAD AN ENDOMETRIAL ABLATION USING THE CERENE DEVICE ON (B)(6) 2025 TO TREAT HER HEAVY MENSTRUAL BLEEDING. STARTING (B)(6), THE PATIENT EXPERIENCED HEAVY BLEEDING, WHICH CONTINUED THEREAFTER. TEN DAYS PRIOR TO REPORTING THESE SYMPTOMS ON (B)(6), THE PATIENT SELF-ADMINISTERED 200MG OF PROGESTERONE, AND AS THERE WAS NO CHANGE IN HER BLEEDING, ALSO BEGAN TAKING TRANEXAMIC ACID. AT ONE POINT THE PATIENT DESCRIBED EXPERIENCING HEAVY BLEEDING, UTERINE CLOTS, AND SOMETHING THAT APPEARED TO BE A "UTERINE CAST." THE PATIENT'S HEMOGLOBIN WAS MEASURED APPROXIMATELY (B)(6), AND WAS NORMAL. THE PATIENT'S PHYSICIAN WAS OUT OF TOWN ON VACATION FOR TWO WEEKS, RETURNING (B)(6). THE MANUFACTURER'S MEDICAL LIAISON WAS CONSULTED, WHO STATED THAT THE PHYSICIAN MAY CONSIDER AN ULTRASOUND AND ONE MONTH TRIAL OF AN ORAL CONTRACEPTIVE. AS OF (B)(6), THE PATIENT STATED HER BLEEDING HAD SLOWED DOWN AND SHE WAS FEELING SLIGHTLY BETTER. THE PATIENT WAS STILL TAKING PROGESTERONE AND TRANEXAMIC ACID AND WAS INSTRUCTED TO FOLLOW-UP WITH HER PHYSICIAN AS SOON AS POSSIBLE FOR MEDICAL ADVICE AND TREATMENT. THE MANUFACTURER'S REPRESENTATIVE REVIEWED THE DEVICE LABELING AND EXPECTATIONS POST-PROCEDURE, INCLUDING THAT RESULTS MAY VARY AND CAN TAKE 3-6 MONTHS TO TAKE EFFECT. ON (B)(6), THE PATIENT NOTIFIED THE MANUFACTURER'S REPRESENTATIVE THAT SHE HAD FOLLOWED UP WITH HER PHYSICIAN AND WAS UNDER HER CARE FOR ONGOING TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319053 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other