BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERENE CRYOTHERAPY DEVICE

    MDR report key: 23888879 · Received December 24, 2025

    Report

    Report Number
    3012018285-2025-00011
    Event Type
    Injury
    Date Received
    December 24, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 19, 2025
    Manufacturer
    CHANNEL MEDSYSTEMS, INC.
    Product Code
    MNB
    PMA / PMN Number
    P180032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE DEVICE OR DEVICE HISTORY RECORDS WAS NOT POSSIBLE, AS AN UNKNOWN LOT NUMBER WAS REPORTED AND THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS UNABLE TO BE ISOLATED AS THERE WERE MULTIPLE LOT NUMBERS SOLD TO THIS PHYSICIAN. VASOVAGAL RESPONSE IS COMMON DURING INTRAUTERINE PROCEDURES DUE TO CERVICAL/UTERINE STIMULATION TRIGGERING THE VAGUS NERVE AND LEADING TO PRESYNCOPE OR SYNCOPE. 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 TORADOL. DURING THE PROCEDURE, SHE WAS ADMINISTERED NITROUS OXIDE AND OXYGEN (PRONOX). THE PATIENT APPEARED TO BE TOLERATING THE PROCEDURE WELL WHEN, ABOUT 20 SECONDS BEFORE THE END OF TREATMENT, THE PATIENT BECAME UNRESPONSIVE TO THE NURSE. THE DEVICE WAS PLACED INTO VENTING MODE AND REMOVED FROM THE PATIENT. THE STAFF SUSPECTED A VASOVAGAL REACTION AND MOVED THE PATIENT TO THE FLOOR. THE PATIENT THEN BECAME RESPONSIVE AND HER VITALS RETURNED TO NORMAL WHEN TAKEN BY PARAMEDICS. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AS A PRECAUTION. IN FOLLOW-UP CONVERSATIONS WITH THE OFFICE ADMINISTRATOR TWO WEEKS LATER, IT WAS NOTED THAT THE PATIENT IS DOING WELL AND IS CURRENTLY ON VACATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058083 CERENE CRYOTHERAPY DEVICE ENDOMETRIAL ABLATION DEVICE MNB CHANNEL MEDSYSTEMS, INC. FGS-7000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization NITROUS OXIDE/OXYGEN (PRONOX).| PARACERVICAL BLOCK.| TORADOL.